Electrode paddle for neurostimulation

ABSTRACT

An implantable electrode paddle for use in a neurostimulation system may include a dorsally-projecting lead that allows all of the edges of the electrode paddle to be situated near a vertebral body for stimulation of neural structures. Embodiments may include one or more flanges for cooperating with a vertebral body and thereby stabilizing the electrode paddle. Embodiments of the present invention may also include features to allow an electrode paddle to be divided during surgery. Embodiments of the present invention may also include an electrode paddle having a plurality of paddle sections, wherein at least one of the paddle sections comprises a plurality of asymmetrically configured contacts. Embodiments of the invention include a method of assembling a neurostimulation system and a method of implanting an implantable system in a body, wherein the implantable system includes an electrode paddle that may be divided into a plurality of paddle sections.

FIELD

The present invention is related to medical implants, and moreparticularly, to an implantable electrode for neurostimulation.

BACKGROUND

Electrodes are used to provide electrical stimulation, includingelectrical stimulation of neural structures in patients suffering fromchronic pain. A variety of electrodes and electrode arrays exist foroperation in conjunction with a pulse generator. U.S. Patent ApplicationPublication No. 2006/0136008, incorporated herein by reference in itsentirety, discloses a number of electrode arrays. For example, andreferring to FIG. 1A, an electrode array 10 known in the prior art isshown. The electrode array 10 includes a plurality of electrodes orcontacts 14 located at the distal region 18 of a lead 22. Referring toFIG. 1B, an electrode array 10 is located within an electrode paddle 26.The electrode array 10 is formed of a plurality of contacts 14 situatedwithin the relatively flat electrode paddle 26. Referring now to FIG.1C, two electrode arrays 10 are located within two electrode paddles 26,wherein the leads 22 extend to a common junction 30, and wherein theleads 22 are controlled by a common pulse generator (not shown). For theelectrode array shown in FIG. 1C, each electrode array 10 is formed of aplurality of contacts 14 situated within the relatively flat electrodepaddle 26.

For the above noted electrode arrays, the electrical lead 22 conveys apulse of electrical energy from a pulse generator to the electrodearrays 10. In general, the lead 22 enters the electrode array 10 orpaddle 26 at a proximal end 34 of the electrode array 10 or paddle 26,where the distal end 38 of the lead 22 is co-planar with the electrodearray 10 or paddle 26.

The structure of the existing electrode arrays presents difficulties fora surgeon implanting the electrode paddles within certain areas of thespine because the anatomy of the spine does not necessarily lend itselfto implanting an electrode array directly onto the nerves of the spinewhen the distal end 38 of the lead 22 is also coplanar with theelectrode array 10. That is, the spine is three dimensional, and anelectrode array 10 cannot necessarily be properly positioned within thespinal canal and on the target neural structures of the spine when thedistal end 38 of the electrical lead 22 extends in a coplanarorientation with the electrode paddle 26 containing the electrode array10.

Referring now to FIG. 1D, a partial side view of an electrode paddle 42of the prior art is shown implanted at the cervical vertebrae C1-C2level, and in FIG. 1E, a posterior view of the electrode paddle 42 isshown. For this typical implant configuration, the electrode lead 22extends from a longitudinal end of the electrode paddle 42 in a caudaldirection between the occipital bone and C1. As shown in FIG. 1F, inextension the occipital bone forces the electrode lead 22 downward andpinches the electrode lead 22 against the C1. With repeated motion, theelectrode lead 22 experiences stress that can be detrimental to thestructural integrity of the electrode wire 22 and its connection to theelectrode paddle 42.

To address the spatial limitations resulting from the implant targetlocation and the existing electrode paddle geometries, the surgeon maybe forced to compromise in some fashion, such as by: (1) using analternate and less attractive array configuration; (2) positioning theelectrode array near the target location but not exactly at the desiredtarget location; and/or (3) allowing the spine to bend the distal end ofthe electrical lead at the proximal end of the electrode paddle, therebyrisking the structural integrity of the lead connection to the electrodepaddle. Thus, it would be advantageous to provide an electrical paddlehaving an electrical lead configuration that more appropriatelyaccommodates the anatomical features of the spine.

U.S. Pat. No. 3,724,467, incorporated herein by reference in itsentirety, discloses an electrode paddle having a lead connection thatenters the paddle at an angle of between 15 to 45 degrees. However, thisreference fails to disclose a lead connection that connects to the bodyportion of the electrode paddle along a steep inclination, such as alonga substantially perpendicular alignment. Such a perpendicular alignmentwould be advantageous for implanting at the opening between the L5-Svertebrae.

With regard to use of electrodes to relieve pain, foot pain isnotoriously difficult to treat with intraspinal stimulation. If theelectrode(s) are placed at the spinal cord level, the stimulationeventually goes away from the foot area because other larger nervefibers (mostly the thigh) eventually end up capturing most of thestimulation. In order to maintain the stimulation in the foot area, themost precise and reliable target is the L4, L5, S1, S2 nerve roots atthe L4-L5 spine level. Electrodes placed on these nerve roots willgenerally maintain stimulation in the foot. There are several issueswith stimulation of the lumbar nerve roots for pain. The target nervesare the lumbar dorsal (sensory) roots that carry sensation. Stimulationof the ventral (motor) roots, which are adjacent of the sensory roots,is greatly undesirable because it produces motor contractions. If anelectrode is placed under the lamina, as is necessary with the existingshaped paddle leads, it will exert some degree of pressure on the nerveroots, even if minimal. This amount of pressure is often enough tosqueeze the dorsal roots very close to the ventral roots. A significantside effect of the nerve roots coming closer together is that thestimulation will almost inevitably result in stimulating the motor rootspreferentially, thereby negating the beneficial effects of thestimulation.

In order to avoid activation of the motor roots, a minimal amount ofcompression, if any, must be exerted on the nerve roots. In order toaccomplish this, no bone should be present dorsal to the electrodesplaced on the nerve roots. This presents a difficulty because theexisting commercially-available paddle leads rely on the presence ofbone dorsally to maintain them in place and prevent their displacement.

Another area that has been problematic for electrode placement is theC1-C2 region of the spine. This area of the spinal cord is an excellenttarget for stimulation since all of the nerve fibers coming from theupper and lower extremities converge at the C1-C2 level. A physicianmight, therefore, have the possibility to stimulate all four extremitiesfrom one single target. However, two issues make that placement lessthan ideal with the currently available electrodes. First, since theelectrode(s) are placed entering the spine between the occiput and thearch of C1, they are subjected to a significant amount of motion. Moreparticularly, the cranio-cervical junction has one of the highest motionof any spine segment. This puts the electrode at a very high risk offracturing or possible malfunction. Secondly, the C2 lamina isrelatively thick and tends to push the electrode closer to the spinalcord. As a result, the stimulation current more easily spreads, not onlyto the dorsal columns (a desirable effect), but also to the motorfibers. This will result in undesirable motor contractions that mightnegate the beneficial effects of the stimulation. Even a thinnerelectrode might not obviate that problem. Accordingly, the best solutionis to have the electrode placed in an area where little or no bone willbe present to exert pressure on the electrode.

Yet another area of interest is the T7-T8-T9-T10-T11 area, where aphysician may be trying to achieve stimulation of the dorsal columnsaffecting the lower extremities and the axial lumbar area (which isnotoriously difficult to stimulate). Stimulation of the nerves in theT7-T8-T9-T10-T11 levels is often performed to treat pain in the lowerback and in the lower extremities. Here again, the configuration of thevertebrae and the location of the target neural structures do notnecessarily facilitate ease of treatment using existingcommercially-available electrodes.

In addition, while existing electrodes paddles include some materialalong the boundary of the paddle, the existing electrode paddles do notnecessarily include sufficient material for allowing the electrodepaddle to be anchored or otherwise stabilized within the environment ofthe spinal canal. Thus, it would be advantageous to provide an electrodepaddle that has structure for allowing the electrode paddle to cooperatewith the structure of the vertebrae of the spine for maintaining theposition of the electrode paddle within the spinal canal once it isimplanted, whether or not a laminectomy has been performed.

Another difficulty associated with electrode arrays and electrodepaddles of the prior art is that they are generally provided in aone-piece configuration and do not readily permit the surgeon to modifytheir shape to accommodate the physical attributes of the patient duringsurgery. Accordingly, it would be advantageous to provide an electrodepaddle that accommodated modification during the surgical procedure toallow the surgeon to modify the shape and/or orientation of theelectrode array to suit the patient's needs.

SUMMARY

Various embodiments of the present invention address the shortcomings ofthe prior art. It is to be understood that the present inventionincludes a variety of different versions or embodiments, and thisSummary is not meant to be limiting or all-inclusive. This Summaryprovides some general descriptions of some of the embodiments, but mayalso include some more specific descriptions of certain embodiments.

In at least some embodiments of the present invention, an electrodepaddle is provided for allowing the distal end of an electrode paddle tobe positioned proximate an edge of a vertebra. More particularly, in atleast some embodiments of the present invention, the lead connectionfrom the electrode lead to the electrode paddle includes a substantiallyperpendicular orientation. In addition, in at least some embodiments ofthe present invention an electrode paddle is provided that includes astructure for stabilizing the electrode paddle along the spinal canal ornerve branches associated with the spinal canal. More particularly, inat least some embodiments of the present invention, the electrode paddleincludes one or more flanges that extend from an edge of the electrodepaddle. In at least some embodiments of the present invention anelectrode paddle is provided that can be separated into a plurality ofpaddle sections. Embodiments of the present invention may also includean electrode paddle having a plurality of paddle sections that can beseparated, wherein the paddle sections each include a plurality ofcontacts. In at least some embodiments of the invention, the pluralityof contacts are positioned asymmetrically on each paddle section.

It is also an aspect of the present invention to provide an electrodepaddle that can be used in combination with other previously implantedpulse generators, electrode leads and electrode arrays, where the leadconnection entering the existing electrode array has been broke ordamaged. The current invention allows a surgeon to replace the lead andelectrode array to provide a more suitable electrode array withstructural features that prevent or otherwise mitigate spatial problemsassociated with the broke or damaged electrode array.

The present invention includes a method of assembling a neurostimulationsystem that is implantable in a patient to stimulate a plurality ofnerves/neural fibers. The method includes providing an implantable pulsegenerator and an implantable lead. In addition, the method includesproviding an electrode paddle having a plurality of separable paddlesections, wherein the paddle sections each include a plurality ofcontacts that are not linearly aligned. The electrode paddle can beelectrically connected or interconnectable to the implantable pulsegenerator by the implantable lead.

In accordance with embodiments of the present invention, an implantablesystem for implanting into a patient to stimulate one or more neuralstructures is provided, the implantable system comprising: (a) a way ofgenerating an electrical pulse; (b) a way of transmitting the electricalpulse; and (c) a device for holding a plurality of contacts wherein theplurality of contacts are adapted to be in electrical communication withthe transmitting device and wherein the plurality of contacts areconfigured to carry the electrical pulse to stimulate the one or moreneural structures. The device for holding the contacts preferablyincludes a way of being divided wherein the device for holding isdivisible into a plurality of sections, wherein at least two contactslocated in each section are aligned along a first axis and at least twoadditional contacts in each section are aligned along a second axis, andwherein the first axis and the second axis are transverse to oneanother. In accordance with embodiments of the present invention, thesystem includes a lead connection for perpendicularly interconnecting anelectrical lead to the device that holds the electrodes. The device forholding the contacts may include a body and at least one flange, whereinthe flange extends beyond a longitudinal end or lateral side of the bodyof the device that holds the contacts.

It is noted that the present invention has application to systems thatare implantable within humans, and also has application to veterinarymedicine, wherein the devices and methods described herein may be usedin association with treating, for example, animals, such as horses.

It is also an aspect of the present invention to provide a method ofimplanting an electrode array. Thus, in accordance with embodiments ofthe present invention, a method of installing a neurostimulation systemin a patient is provided. The method includes:

(a) making an incision in a first tissue of the patient, the incisionfor placement of a pulse generator;

(b) making an incision in a second tissue of the patient, the incisionfor placement of at least one electrode paddle, wherein the electrodepaddle includes a plurality of paddle sections, and wherein at least onepaddle section includes a plurality of contacts that are configuredasymmetrically.

Various embodiments of the present invention are set forth in theattached figures and in the detailed description of the invention asprovided herein and as embodied by the claims. It should be understood,however, that this Summary does not contain all of the aspects andembodiments of the present invention, is not meant to be limiting orrestrictive in any manner, and that the invention as disclosed herein isand will be understood by those of ordinary skill in the art toencompass obvious improvements and modifications thereto.

Additional advantages of the present invention will become readilyapparent from the following discussion, particularly when taken togetherwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C are plan views of electrode arrays known in the prior art;

FIG. 1D is a partial side elevation view of a electrode paddle of theprior art, wherein the electrode paddle is shown implanted proximate theC1 and C2 cervical vertebrae, wherein the paddle has been inserted in acaudal direction entering the spine between the occipital bone and C1;

FIG. 1E is a rear view of an electrode paddle implanted proximate the C1and C2 cervical vertebrae;

FIGS. 1F and 1G are additional views of the electrode paddle of FIG. 1Dwhere movement of cervical vertebrae has occurred;

FIG. 2 is a plan view of an electrical stimulation system in accordancewith embodiments of the present invention;

FIG. 3 is a plan view of an electrode paddle in accordance withembodiments of the present invention;

FIG. 4 is a side elevation view of the device shown in FIG. 3;

FIG. 5 is a plan view of the device shown in FIG. 3 after it has beendivided;

FIG. 6 is a cross-sectional view taken along line 6-6 as shown in FIG.5;

FIG. 7 is a cross-sectional view taken along line 7-7 as shown in FIG.5;

FIG. 8 is plan view of an electrode paddle in accordance with at leastone embodiment of the present invention;

FIG. 9 is plan view of an electrode paddle in accordance with at leastone embodiment of the present invention;

FIG. 10 is plan view of an electrode paddle in accordance with at leastone embodiment of the present invention;

FIG. 11 is plan view of an electrode paddle in accordance with at leastone embodiment of the present invention;

FIG. 12 is a plan view of an electrode paddle in accordance withembodiments of the present invention;

FIG. 13 is a plan view of the device shown in FIG. 12 after it has beendivided;

FIG. 14 is a cross-sectional view taken along line 14-14 as shown inFIG. 13;

FIG. 15 is a cross-sectional view taken along line 15-15 as shown inFIG. 13;

FIG. 16 is plan view of an electrode paddle in accordance with at leastone embodiment of the present invention;

FIG. 17 is plan view of an electrode paddle in accordance with at leastone embodiment of the present invention;

FIGS. 18A and 18B are plan views of electrode paddles in accordance withat least one embodiment of the present invention;

FIG. 19A is plan view of an electrode paddle in accordance with at leastone embodiment of the present invention;

FIGS. 19B and 19C are perspective views of an electrode paddle inaccordance with at least one embodiment of the present invention;

FIG. 20 is plan view of an electrode paddle in accordance with at leastone embodiment of the present invention;

FIGS. 21A and 21B are plan views of electrode paddles in accordance withat least one embodiment of the present invention;

FIG. 21C is a perspective view of the electrode paddle shown in FIG.21B;

FIG. 22 is plan view of an electrode paddle in accordance with at leastone embodiment of the present invention;

FIGS. 23A and 23B are plan views of electrode paddles in accordance withat least one embodiment of the present invention;

FIG. 24 is a perspective view of an electrode paddle in accordance withat least one embodiment of the present invention;

FIGS. 25-38 are posterior views of the L5-S vertebrae with exemplaryuses of embodiments of the present invention;

FIGS. 39-43 are side and posterior views of the C1-C2 cervical vertebraewith exemplary uses of embodiments of the present invention; and

FIGS. 44-46 are posterior views of the T9-T11 thoracic vertebrae withexemplary uses of embodiments of the present invention.

The drawings are not necessarily to scale.

DETAILED DESCRIPTION

Embodiments of the present invention are directed to an implantableelectrode paddle for use in a neurostimulation system. Embodiments ofthe present invention may include a dorsally-projecting lead that allowsall of the edges of the electrode paddle to be situated near a vertebralbody. Embodiments of the may also include one or more flanges forcooperating with a vertebral body and thereby stabilizing the electrodepaddle. In addition, embodiments of the present invention may alsoinclude features to allow an electrode paddle to be divided duringsurgery. It is also an aspect of the present invention to provide anelectrode paddle that can be used in combination with other previouslyimplanted pulse generators, electrode leads and electrode arrays, wherethe lead connection entering the existing electrode array has been brokeor damaged. Embodiments of the present invention are suitable forallowing a surgeon to replace an existing lead and electrode array toprovide a more suitable electrode array with structural features thatprevent or otherwise mitigate spatial problems associated with a brokenor damaged lead or electrode array. As discussed below, still otherembodiments of the present invention are directed at methods of usingthe electrode paddle.

Referring now to FIG. 2, and in accordance with embodiments of thepresent invention, an electrical stimulation system 200 is shown. Theelectrical stimulation system 200 comprises an implantable pulsegenerator 204, a lead body 208, and an electrode paddle 212. The leadbody 208 includes a proximal end 210 that is connected (or isinterconnectable) to the implantable pulse generator 204. The distal end214 of the lead body 208 includes the electrode paddle 212 comprising anelectrode array 216 that includes a plurality of electrical contacts220. The lead body 208 may include a common junction 224 where the leadbodies 208 to the paddle sections join.

Referring now to FIG. 3, additional detail of an embodiment of anelectrode paddle 212 is shown. In at least one embodiment of theinvention, the electrode paddle 212 comprises a paddle body 300 thatincludes a plurality of paddle sections 304 a and 304 b, wherein thepaddle sections 304 a, 304 b are initially connected to one another.More particularly, the electrode paddle 212 includes a webbing portion308 that is configured for dividing the electrode paddle 212 into aplurality of sections. In accordance with at least some embodiments ofthe invention, and as best seen in FIG. 4, the webbing 308 comprises agroove 310 oriented along the longitudinal axis L-L of the electrodepaddle 212. The groove 310 facilitates separation of the paddle sections304 a and 304 b if the surgeon decides to divide the electrode paddle212 prior to or during the course of the implant procedure. Otheralternative structure may also be used to facilitate ease of dividingthe electrode paddle 212. For example, a series of perforations 312 maybe used (as shown in FIG. 12) for facilitating separation of the paddlesections 304 a and 304 b. Other alternative configurations are alsowithin the scope of the invention. For example, as seen in FIG. 8, thewebbing may have a score 314 for facilitating separation of the paddlesections. Alternatively, the webbing 308 may be imperforated, butreadily capable of being cut by the surgeon or his or her staff. Thus, avariety of ways are possible to configure the electrode paddle 212 fordivision into a number of separate paddle sections, and such possibleconfigurations are within the scope of the present invention. Thewebbing 308 serves not only as an area of the electrode paddle 212 forseparating one paddle section from another, but the webbing also servesto both isolate and electrically insulate the contacts 220 of one paddlesection from the electrodes of the one or more other paddle sections,such as by isolating and insulating the contacts 220 of paddle section304 a from the contacts 220 of paddle section 304 b. Accordingly, thematerial forming the body of the paddle around the contacts 220 is anelectrically insulating material, and the webbing 308 is preferablyformed of an electrically insulating material. Although two paddlesection 304 a and 304 b are shown in several of the figures, it is to beunderstood that the electrode paddles may comprise more than two paddlesections, such as three paddle sections, four paddle sections, etc.

Referring now to FIG. 5, there is shown the electrode paddle 212 of FIG.3 divided into the separate paddle sections 304 a and 304 b. As can beseen in FIG. 5, the electrode paddle 212 has been divided along itslongitudinal axis L-L. However, the electrode paddle 212 could bedivided into separate paddle sections that are not equal in size.

Referring now to FIGS. 3 and 5-7, and in accordance with embodiments ofthe present invention, the electrode paddle 212 includes a plurality oflead connections 316, wherein the lead connections 316 are spaced apartfrom the edges of the electrode paddle 212. More particularly, the leadconnections 316 do not connect to the electrode paddle 212 at a lateralside 336 or longitudinal end 340 of the electrode paddle 212. Instead,the lead connection 316 is non-planar with the electrode paddle 212.That is, the lead connection 316 enters the paddle from the dorsal orback side 320 of the electrode paddle 212 relative to the front side324, where the front side 324 corresponds to the surface of theelectrode paddle 212 for contacting the contacts 220 with the intendedneural structures of the patient. The lead connections 316 may include areinforced portion or sheath 328 at the distal end 330 of the lead 208,wherein the sheath 328 serves to protect the wires or filaments withinthe lead 208 from being damaged where there is a bend in the wiring fromthe lead 208 to the electrode paddle 212.

Referring to FIGS. 3-7, and in accordance with embodiments of thepresent invention, the electrode paddle 212 includes one or more flanges332 along it sides. For the electrode paddle 212 shown in FIGS. 3-7, theflanges 332 are located along the lateral sides 336. However, it is tobe understood that the one or more flanges 332 could also be locatedalong one or both of the longitudinal ends 340 of the electrode paddle212. The flanges are not necessarily used to suture the electrode paddle212 to the tissue of the patient, but serve to hold the electrode paddle212 in place by positioning the flange in contact with an anatomicalstructure, such as the lamina of a vertebra, where the vertebra holdsthe flange, and therefore the electrode paddle 212 in place. It isfurther noted that sutures may also be used to hold the electrode paddlein place.

In accordance with embodiments of the present invention, an electrodepaddle 212 may comprise only one flange 332. For example, an electrodepaddle 212 may comprise a flange 332 located on a lateral side 336, butnot on the other lateral side 340. Such a configuration has applicationwhere the flange on the lateral side 336 is used to secure the electrodepaddle under a portion of one or more vertebra, but a flange is notneeded on the other lateral side 340.

In accordance with embodiments of the present invention, the flanges 332comprise an extension of the material forming the electrode paddle 212,although a different type of material may be used for the flanges 332.In use, the surgeon positions the electrode paddle 212 such that thecontacts 220 of the electrode paddle are in electrical communicationwith the targeted neural structures. The surgeon also positions or tucksthe one or more flanges 332 under the adjacent vertebra, or otherwisepositions the flanges to assist in stabilizing the location of theelectrode paddle 212. Thus, the flanges 332 serve to hold or assist inholding the electrode paddle 212 in place. The flanges 332 may betrimmed by the surgeon during the implantation procedure to furthercustomize the flanges 332 to fit the physical needs of the patient.

Referring now to electrode paddle 1800′ of FIG. 18B, a modified versionof the electrode paddle 1800 is shown, wherein electrode paddle 1800′includes paddle sections 1804 a′ and 1804 b′, with contacts 220 a-dconfigured similar to those for electrode paddle 1800 discussed above.However, paddle sections 1804 a′ and 1804 b′ include a diagonallyoriented interior edge portion 1824, in contrast to a longitudinallyoriented interior edge portion 1828 and laterally oriented interior edgeportion 1832 of electrode paddle 1800. Alternatively, the area betweenpaddle sections 1804 a and 1804 b of electrode paddle 1800, and betweenpaddle sections 1804 a′ and 1804 b′ of electrode paddle 1800′, may be acontinuous webbing 308, with or without a groove 310, perforations 312,or score 314. For the electrode paddle 1800′ shown in FIG. 18B, twowebbing bridges 1806 join the paddle sections 1804 a′ and 1804 b′. Aswith electrode paddle 1800, electrode paddle 1800′ includes leadconnections 1808 a′ and 1808 b′ that preferably enter each paddlesection 1804 a′-b′, respectively, from an orientation that is transverseto the dorsal surface 1812 of the paddle section 1804 a′-b′, such as inan orientation that is substantially perpendicular to the dorsal surface1812. Electrode paddle 1800′ preferably comprises dimensions similar tothose described for electrode paddle 1800.

Referring still to FIG. 8, each paddle section also has a paddle sectionwidth 814, and in at least some embodiments of the invention, the widthsof the various paddle sections are substantially equal, although mixedwidth sizes are also within the scope of the present invention. Theflange 332 has a flange width 818 as measured between the lateral side336 of the paddle section 304 and the outer lateral edge 822 of theflange 332. By way of example and not limitation, the flange width 818is between about 50 to 75% of the paddle section width 814, and morepreferably, the flange width 818 is between about 55 to 70% of thepaddle section width 814, and more preferably yet, the flange width 818is between about 58 to 65% of the paddle section width 814.

Referring now to FIG. 9, an electrode paddle 212 is shown wherein theflanges 332 comprise a relatively longer length than the flanges 332illustrated in FIG. 8. For the electrode paddle 212 shown in FIG. 9, theinner flange length 806 is about 75% of the paddle length 802, and theouter flange length 810 is about 75% of the length of the inner flangelength 806. Such longer flanges 332 may include structure to allow theflange 332 to more easily accommodate the anatomy where it is intendedto be located. By way of example and not limitation, the flange 332 mayinclude one or more thinned sections and/or grooves 826 to allow theflange to bend more easily along its longitudinal length. The paddlesections 304 may also include structure to allow some articulation ofthe paddle section 304. Such articulation structure reduces the tendencyof the flange 332 and/or the paddle section 304 to move due to twistingor other motion by the patient after the electrode paddle 212 has beenimplanted.

Still referring to FIG. 9, consistent with the lead connections 316shown in FIG. 3 and FIG. 8, the lead connections 902 are shown spacedapart from the lateral sides 336 of the electrode paddle 212, and spacedapart from the longitudinal ends 340 of the electrode paddle 212.However, the lead connections 902 shown in FIG. 9 are not located at thelongitudinal center of the electrode paddle 212. Rather, the leadconnections 902 are offset longitudinally from the longitudinal center Cof the electrode paddle 212. The longitudinally offset lead connections902 allow a larger portion of the electrode paddle 212 to be placedunder the lamina of a vertebra, while still allowing the lead 208 toenter the electrode paddle 212 from an orientation transverse to thesubstantially planar top surface 320 of the electrode paddle 212.

Referring now to FIG. 10, an electrode paddle 212 in accordance withembodiments of the present invention is shown, wherein the electrodepaddle 212 includes a plurality of flanges 332 along each of its lateralsides 336. As depicted in FIG. 10, the flanges 332 include a gap 1002along their outer lateral edge 822 that extends to the lateral sides 336of the electrode paddle 212.

Referring now to FIG. 11, an electrode paddle 212 in accordance withembodiments of the present invention is shown, wherein the electrodepaddle 212 includes a plurality of flanges 332, including flanges 332along the longitudinal ends 340 of the electrode paddle.

Referring now to FIG. 12, an electrode paddle 212 in accordance withembodiments of the present invention is shown, wherein the electrodepaddle 212 includes a plurality of paddle sections 304 that may beseparated along a webbing 308, where the webbing is transverse to thelongitudinal axis L-L of the electrode paddle 212. In comparing theelectrode paddle 212 of FIG. 3 to the electrode paddle 212 of FIG. 12,it is apparent that the paddle sections 304 of the electrode paddle 212of FIG. 3 are separable along an axis substantially parallel to thelongitudinal axis L-L of the electrode paddle 212, while the paddlesections 304 of the electrode paddle 212 of FIG. 12 are separable alongan axis substantially perpendicular to the longitudinal axis L-L of theelectrode paddle 212. FIG. 13 shows the electrode paddle 304 a and 304 bafter they have been separated along perforations 312.

Referring now to FIGS. 14 and 15, cross-sections through paddle section304 b are shown. These cross sections further illustrate thesubstantially perpendicular alignment of the lead connection 316 to thetop surface 320 of the electrode paddle 212. FIGS. 14 and 15 alsoillustrate that the flanges 332 may be angled relative to thesubstantially flat nature of the paddle body 300 of the electrode paddle212.

Referring now to FIG. 16, an electrode paddle 1600 is shown thatcomprises a paddle body 1604 that is unitary and does not includestructure for separation into smaller paddle sections. However, theelectrode paddle may comprise a flange 1608. In accordance with at leastsome embodiments of the present invention, the flange 1608 has a surfacearea larger than the surface area of the paddle body 1604. The relativesize of the flange 1608 allows for a relatively small electrode array216 to be held in place by a vertebra. In addition, a substantiallyperpendicular oriented lead connection 316 may be used to allow theedges of the electrode array to be position near a vertebra while notcausing a spatial problem between the lead and the sides of theelectrode paddle in relation to the patients anatomical structures atthe implant site.

Referring now to FIG. 17, an electrode paddle 1700 is shown thatcomprises a paddle body 1704 that is unitary and does not includestructure for separation into smaller paddle sections. However, theelectrode paddle 1700 comprises a flange 332 and a longitudinally offsetlead connection 902. In addition, the electrode paddle 1700 may includea plurality of electrical contacts (also referred to herein as“contacts”) 220 wherein the contacts 220 are configured in anasymmetrical pattern relative to the longitudinal axis L-L of theelectrode paddle 1700.

As described in the following paragraphs, embodiments of the presentinvention also include electrode paddles having a plurality of contacts,wherein the contacts are configured on a plurality of paddle sections,and wherein the contacts within each paddle section are arranged in anon-linear orientation. Embodiments of the present invention alsoinclude electrode paddles having a plurality of paddle sections whereinat least one of the paddle sections includes a plurality of contactsarranged in a non-linear pattern, and wherein one of the paddle sectionsmay not include a plurality of contacts, or where the contacts arelocated in a linear arrangement. The various possible configurationsnoted above offer advantages for placement and stimulation ofnerves/neural structures, particularly neural structures located atcertain areas of the spine.

Referring now to FIG. 18A, and in accordance with embodiments of thepresent invention, an electrode paddle 1800 is shown, the electrodepaddle 1800 having two paddle sections 1804 a and 1804 b. Various waysof interconnecting the paddle sections 1804 a and 1804 b are encompassedby the present invention. For the electrode paddle 1800 shown in FIG.18A, two webbing bridges 1806 join the paddle sections 1804 a and 1804b. Both paddle sections 1804 a or 1804 b include a plurality of contacts220, where the contacts 220 are arranged in a non-linear pattern.Electrode paddle 1800 includes eight contacts, wherein four contacts arepositioned on each paddle section 1804 a and 1804 b.

For the electrode paddle 1800, paddle sections 1804 a and 1804 b eachinclude three contacts 220 a, 220 b and 220 c aligned in a linearorientation, with a fourth contact 220 d located off the axis ofcontacts 220 a-c. More particularly, the contacts 220 a-c are orientedco-axially and in a direction substantially parallel with thelongitudinal axis L-L of the electrode paddle 1800, and contact 220 d islocated substantially adjacent an end contact of the co-axially orientedcontacts 220 a-c, such as adjacent contact 220 c.

The contacts 220 a-d are preferably individually and separatelycontrollable using an implantable pulse generator. In addition, thecontacts may also be controlled in groups of more than one. By way ofexample and not limitation, the contacts that are co-axially aligned andsubstantially parallel with the longitudinal axis L-L, that is, contacts220 a-c in FIG. 18A, are preferably separately controllable fromcontacts 220 d. Furthermore, contacts 220 c-d are also separatelycontrollable from contacts 220 a-b. As will be discussed and illustratedin more detail below, the non-linear arrangement of contacts 220 a-dallows the electrode paddle sections 1804 a-b to be implanted forstimulation of different neural structures to address pain at differentareas of the patient's body.

For electrode paddle 1800, lead connections 1808 a and 1808 b preferablyenter each paddle section 1804 a-b, respectively, from an orientationthat is transverse to the dorsal surface 1812 of the paddle section 1804a-b, such as in an orientation that is substantially perpendicular tothe dorsal surface 1812. However, as with all electrode paddlesdescribed herein, it is to be understood that the electrode lead couldalso enter at an orientation that is substantially co-planar with theelectrode paddle, such as at a longitudinal end of the paddle 1800, andsuch embodiments are also encompassed by the present invention.

The electrode paddle 1800 typically has a width 1816 between about 10 to15 mm wide, and more preferably, about 13 mm wide, with a length 1820 ofbetween about 15 to 25 mm long, and more preferably, about 20 mm long.For electrode paddle 1800, each paddle section 1804 a-b is substantiallyL shaped as viewed from either a top or bottom plan view of the paddlesections 1800 a-b.

Referring now to FIG. 8, and in accordance with embodiments of thepresent invention, an electrode paddle 212 is shown that includes afirst paddle section 304 a and a second paddle section 304 b with oneflange 332 located on each of the lateral sides 336. As depicted in FIG.8, the electrode paddle 212 has a paddle length 802 and the flange 332has an outer flange length 810 and an inner flange length 806, where theinner flange length 806 is measured at the junction between theelectrode paddle 212 and the flange 332. In accordance with embodimentsof the present invention, flange 332 is centered along the paddle length802. In addition, by way of example and not limitation, the inner flangelength 806 is about 33% of the paddle length 802, and the outer flangelength 810 is about 50% of the length of the inner flange length 806.Although shown in other drawings and described further below, otherratios from those given above are within the scope of the presentinvention.

Referring now to FIG. 19A, electrode paddle 1800 is shown whereininterior paddle section connectors 1900 are located along thelongitudinally oriented interior edge portion 1828 and the laterallyoriented interior edge portion 1832. The interior paddle sectionconnectors 1900 allow the surgeon or his or her staff to cut and trimthe interior paddle section connectors 1900 before or during surgery toaccommodate the patient's neuron-stimulation needs. FIG. 19A furtherillustrates an arrangement of flanges, wherein longitudinal flanges 1904are located on the longitudinal ends 1908 of the electrode paddle 1800,and lateral flanges 1912 are located on the lateral sides 1916 of theelectrode paddle 1800. As discussed previously, the flanges providestructure connected to the electrode paddle 1800 that is spaced apartfrom the contacts 220 and can be positioned under the lamina of one ormore vertebra for holding and maintaining the position of the electrodepaddle 1800 or its sections 1804 a-b. The longitudinal flanges 1904 andlateral flanges 1912 may be a specific size, or alternatively, thelongitudinal flanges 1904 and lateral flanges 1912 may be oversized toallow the surgeon or the surgeon's staff to trim them to accommodate thepatient's physiological needs. As those skilled in the art willappreciate, the longitudinal flanges 1904 and lateral flanges 1912 canalso be removed from the electrode paddle 1800 or its paddle sections1804 a and 1804 b, such as by cutting the flanges during or prior tosurgery. The longitudinal flanges 1904 and lateral flanges 1912 shown inFIG. 19A also apply to other electrode paddles as described herein, suchas electrodes paddles 212 and 1800′.

Referring now to FIGS. 19B and 19C, perspective views of the electrodepaddle 1800 of FIG. 19A are shown, wherein the electrode paddle 1800does not include longitudinal flanges 1904 and lateral flanges 1912.Leads 208 for controlling the contacts 220 a-d on each paddle section1804 a-b are shown, wherein the leads 208 carry the electrical currentfrom the implantable pulse generator (not shown in FIGS. 19B-C) to thecontacts 220 a-d by way of the lead connections 1808 a and 1808 b.

Referring now to FIG. 20, electrode paddle 1800 is shown having a pairof exterior paddle section connectors 2000 with one exterior paddlesection connector 2000 located at each longitudinal end 1908 of theelectrode paddle 1800. The exterior paddle section connectors 2000interconnect the paddle sections 1804 a and 1804 b, and may be cut andtrimmed to separate the two paddle sections 1804 a and 1804 b. Theexterior paddle section connectors 2000 shown in FIG. 20 also apply toother electrode paddles as described herein, such as electrodes paddles212 and 1800′.

Referring now to FIGS. 21A-21C, an electrode paddle 1800 is shown FIG.21A having a plurality of flanges, including lateral flanges 1912 andbridging longitudinal flanges 2100 at the longitudinal ends 1908 of theelectrode paddle 1800. FIGS. 21B and 21C illustrate electrode paddle1800′ having a plurality of flanges, including lateral flanges 1912 andbridging longitudinal flanges 2100 at the longitudinal ends 1908 of theelectrode paddle 1800′. The bridging longitudinal flanges 2100 extendalong the longitudinal ends of both paddle sections 1804 a and 1804 b(or paddle sections 1804 a′ and 1804 b′ in the case of electrode paddle1800′), and interconnect paddle sections 1804 a and 1804 b (or paddlesections 1804 a′ and 1804 b′ in the case of electrode paddle 1800′).Accordingly, to divide the electrode paddle 1800 of FIG. 21A intoseparate paddle sections 1804 a and 1804 b, the surgeon or his or herstaff can cut the bridging longitudinal flanges 2100 along a lateralorientation, such as at lateral cut line 2104, thereby removing thebridging longitudinal flanges 2100 from the paddle sections 1804 a and1804 b, or the bridging longitudinal flanges 2100 can be cut alonglongitudinal cut line 2108 to maintain flange portions 2100 a and 2100 bof the bridging longitudinal flanges 2100 along the longitudinal ends ofthe paddle sections 1804 a and 1804 b. As those skilled in the art willappreciate, one or more of the lateral flanges 1912 and bridginglongitudinal flanges 2100 can be removed from the electrode paddle 1800or its paddle sections 1804 a and 1804 b, such as by cutting the flangesduring or prior to surgery. For example, lateral flanges 1912 can beremoved by cutting the lateral flange 1912 at cut line 2112. As thoseskilled in the art will appreciate, electrode paddle 1800′ of FIGS. 21Band 21C may be modified similarly. Bridging longitudinal flanges 2100may be used with other electrode paddles described herein, such aselectrode paddles 212 and 2200 (discussed below).

Referring now to FIG. 22, an electrode paddle 2200 in accordance withembodiments of the present invention is shown. The electrode paddle 2200includes two paddle sections 2204 a and 2204 b. Both paddle sections2204 a and 2204 b include a plurality of contacts 220, where thecontacts 220 are arranged in a non-linear pattern. Electrode paddle 2200includes sixteen contacts, wherein eight contacts are positioned on eachpaddle section 2204 a and 2204 b.

For the electrode paddle 2200 shown in FIG. 22, paddle sections 2204 aand 2204 b each include three contacts 220 a, 220 b and 220 c aligned ina linear orientation substantially along the longitudinal axis L-L ofthe electrode paddle 2200. The electrode paddle sections 2204 a and 2204b also include four additional contacts 220 d, 220 e, 220 f, and 220 galigned along an axis transverse to the longitudinal axis L-L, and morepreferably, aligned along an axis A-A substantially perpendicular to thelongitudinal axis L-L. The contacts 220 d-g may also be aligned with oneof the contacts 220 a-c; however, for the exemplary contactsconfiguration shown in FIG. 22, none of the contacts 220 a-c are alignedwith contacts 220 d-g. The paddle sections 2204 a and 2204 furtherinclude eighth contacts 220 h located off the longitudinal axis L-L ofcontacts 220 a-c and spaced apart from the transverse axis along whichcontacts 220 d-g are located. More particularly, contact 220 h ispreferably located substantially adjacent and longitudinally alignedwith an end contact of the co-axially oriented contacts 220 d-g, such ascontact 220 g as seen in paddle section 2200 a, or contact 220 d as seenin paddle section 2204 b. It will be appreciated by those skilled in theart that alternative contacts configurations to those described aboveare possible, and such configurations are within the scope of thepresent invention.

The contacts 220 a-h are preferably individually and separatelycontrollable using the implantable pulse generator. In addition, thecontacts may also be controlled in groups of more than one. By way ofexample and not limitation, the contacts that are co-axially aligned andsubstantially parallel to or co-located with the longitudinal axis L-L,that is, contacts 220 a-c in FIG. 22, are preferably separatelycontrollable from contacts 220 d-g. Furthermore, contacts 220 g-h arealso separately controllable from contacts 220 a-c. As will be discussedand illustrated in more detail below, the non-linear arrangement ofcontacts 220 a-h allows the electrode paddle sections 2204 a-b to beimplanted for stimulation of different neural structures to address painat different areas of the patient's body.

Referring still to FIG. 22, for the electrode paddles 2204 a and 2204 b,lead connections 2208 a and 2208 b preferably enter each paddle section2204 a-b, respectively, from an orientation that is transverse to thedorsal surface 2212 of the paddle sections 2204 a-b, such as in anorientation that is substantially perpendicular to the dorsal surface2212. However, as with all electrode paddles described herein, it is tobe understood that the electrode lead could also enter at an orientationthat is substantially co-planar with the electrode paddle, such as at alongitudinal end of the paddle 2200, and such embodiments areencompassed by the present invention.

The electrode paddle 2200 typically has a width 2216 between about 15 to25 mm wide, and more preferably, about 20 mm wide. In addition, theelectrode paddle 2200 typically has a length 2220 of between about 35 to55 mm long, and more preferably, about 45 mm long.

The area between the paddle sections 2204 a and 2204 b may comprise acontinuous webbing, with or without a groove 310, perforations 312, orscore 314. In accordance with at least one embodiment of the presentinvention, the electrode paddle 2200 comprises a longitudinally orientedinterior edge portion 2228 and a laterally oriented interior edgeportion 2232. However, it will be appreciated by those skilled in theart that alternative orientations for the interior edges of theelectrode paddle 2200 are possible, and such configurations are withinthe scope of the present invention. As shown in FIG. 22, the paddlesections 2204 a and 2204 b are interconnected by exterior paddle sectionconnectors 2236.

Referring now to FIG. 23A, and in accordance with at least oneembodiment of the present invention, the paddle sections 2204 a and 2204b of electrode paddle 2200 are interconnected by interior paddle sectionconnectors 2300. The interior paddle section connectors 2300 are locatedalong the longitudinally oriented interior edge portion 2228 and thelaterally oriented interior edge portion 2232. For the electrode paddle2200 shown in FIG. 23B, two webbing bridges 2304 join the paddlesections 2204 a and 2204 b.

Referring now to FIG. 24, a perspective view of electrode paddle 2200 isshown. The paddle sections 2204 a and 2204 b of FIG. 24 each include alongitudinal flange 2404 located on the longitudinal ends 2408 of theelectrode paddle 2200, and lateral flanges 2412 are located on thelateral sides 2416 of the electrode paddle 2200. As those skilled in theart will appreciate, the electrode 2200 may use bridging lateral flangesto interconnect the paddle sections 2204 a and 2204 b, wherein theflanges can be cut in a direction perpendicular to the longitudinal axisof the electrode paddle 2200 to separate the paddle sections 2204 a and2204 b. Such a flange would be similar in structure to the bridginglongitudinal flanges 2100 shown in FIG. 21A.

The longitudinal flanges 2404 and lateral flanges 2412 provide structureconnected to the electrode paddle 2200 that is spaced apart from thecontacts 220 and can be positioned under the lamina of one or morevertebra for holding and maintaining the position of the electrodepaddle 2200 or its paddle sections 2204 a-b. The longitudinal flanges2404 and lateral flanges 2412 may be a specific size, or alternatively,the flanges longitudinal flanges 2404 and lateral flanges 2412 may beoversized to allow the surgeon or the surgeon's staff to trim them toaccommodate the patient's physiological needs. The longitudinal flanges2404 and lateral flanges 2412 can also be removed from the electrodepaddle 2200 or its paddle sections 2204 a and 2204 b, such as by cuttingthe flanges during or prior to surgery.

Various embodiments of the present invention are particularly useful fortreatment of neural structures accessible between the first cervicalvertebra (C1) and second cervical vertebra (C2), between the seventh,eighth, ninth, tenth and eleventh thoracic vertebrae (T7-T11), andbetween the, fourth lumbar vertebra (L4), fifth lumbar vertebra (L5) andthe sacrum (S). More particularly, because of the distribution of neuralstructures and the configuration of the above noted vertebrae, theplacement of an electrode paddles in accordance with embodiments of thepresent invention can be particularly useful.

In order to facilitate placement of an electrode paddle in the vicinityof the target neural structures, a surgeon may perform a partiallaminectomy to remove a portion of one or more vertebrae. The electrodepaddle can then be positioned such that the electrodes are not pressedagainst the neural structures by the dorsal bony structures, but rather,the electrode paddles are held in place, for example, by one or moreflanges that are inserted or tucked under the lamina of the vertebra tohold the electrode paddle in place. Several of the figures illustratelocations of partial laminectomies that may be performed; however, theseexamples are provided for illustrative purposes only, and are notintended to be limiting nor fully illustrative of all occasions when apartial laminectomy may be necessary or advantageous. It is furthernoted that the electrode paddles presented herein may be used to treat avariety of indications. Thus, the examples shown are not meant to belimiting nor are they the full possible range of orientations and usesof the electrode paddles described herein. Accordingly, although eachelectrode paddle described herein is not illustrated for use in everypossible orientation at every possible anatomical treatment location, anumber of examples are presented to illustrate possible uses of theelectrode paddles of the present invention, and those skilled in the artwill appreciate that other uses and/or orientations are readilypossible.

Referring now to FIGS. 25-38, and by way of example and not limitation,several illustrative examples of the placement of the electrode paddlesof the present invention between the L5-S1 vertebrae are shown. FIG. 25illustrates the L5-S1 vertebrae with a single electrode paddle 1700oriented with its longitudinal axis L-L aligned transverse to theorientation of the spine. The electrode paddle 1700 advantageouslyincludes a lead connection 902 that is offset from longitudinal center Cof the electrode paddle 1700. The electrode paddle 1700 also includesone flange 332 located along a lateral side 336 of the electrode paddle1700. FIG. 25 further illustrates the location of a partial laminectomy,wherein some bone of the sacrum has been removed so that the electrodesof the electrode paddle 1700 are not pressed against the neuralstructures. However, the flange 332 is tucked under a portion of thesacrum to maintain the location of the electrode paddle 1700.

FIG. 26 illustrates the L5-S1 vertebrae with first and second paddlesections oriented transverse to each other. More particularly, paddlesection 304 a is oriented with its longitudinal axis L-L nearly parallelto the patient's spine, while detached paddle section 304 b is alignedsubstantially perpendicular to the orientation of the spine. Paddlesection 304 a includes a lead connection 316 at substantially thelongitudinal center of the paddle section 304 a, while paddle section304 b includes a lead connection 902 offset from the longitudinal centerof the paddle section 304 b. The combination of the paddle sections 304a and 304 b as shown in FIG. 26 allows a single implantable pulsegenerator 204 to provide electrical stimulation to two paddle sections,that is, paddle sections 304 a and 304 b, where the electrical signal isconveyed along a single electrode lead 208 that divides to provide theelectrical signal to the paddle sections 304 a and 304 b.

FIG. 27 illustrates the L5-S1 vertebrae with first and second paddlesections oriented transverse to each other. More particularly, paddlesection 304 a is oriented with its longitudinal axis L-L alignedtransverse to the patient's spine, while detached paddle section 304 bis aligned substantially parallel to the orientation of the spine. Uponcomparing the orientation of the paddle sections 304 a and 304 b shownin FIGS. 26 and 27, it is apparent that the present invention providesthe surgeon the ability to orient the paddle sections to stimulate theneural structures necessary to treat the patient as may be needed. Forexample, as shown in FIG. 26, paddle section 304 a is aligned tostimulate the L5 and S1 nerve roots, while in FIG. 27 the paddle section304 a is aligned transverse to the L5 and S1 nerve roots to also allowstimulation of the S2 nerve root.

FIG. 28 illustrates the L5-S1 vertebrae with an electrode paddle 212,where the electrode paddle 212 is undivided so that paddle section 304 ais connected to paddle section 304 b. With flanges 332 and the dorsallypositioned lead connections 316, the electrode paddle 212 can bepositioned to stimulate the desired neural structures.

FIG. 29 illustrates the L5-S1 vertebrae with a single electrode paddle1700 oriented with its longitudinal axis L-L aligned substantiallyparallel to the orientation of the S3-S5 nerve roots. For the electrodepaddle 1700 shown in FIG. 29, the dorsally projecting lead connection316 allows the electrode paddle to cover the targeted S3-S5 nerve roots.

FIG. 30 illustrates the L5-S vertebrae with a single electrode paddle1700 oriented with its longitudinal axis L-L aligned nearly parallel tothe orientation of the spine to stimulate the L5, S1 and S2 nerve roots.For the electrode paddle 1700 shown in FIG. 30, the dorsally projectinglead connection 316 allows the electrode paddle to cover the targetednerve roots.

FIG. 31 illustrates the L5-S vertebrae with two paddle sections 304 aand 304 b. The two paddle sections 304 a and 304 b are positioned withone paddle section on each side of the spinous process, and with thepaddle sections 304 a and 304 b oriented with their longitudinal axisL-L aligned nearly parallel to the orientation of the spine tobilaterally stimulate the L5 and S1 nerve roots. The dorsally projectinglead connection 316 allows the paddle sections 304 a and 304 b to coverthe targeted nerve roots.

FIG. 32 illustrates the L5-S1 vertebrae with two paddle sections 304 aand 304 b, where the paddle sections 304 a and 304 b correspond to thoseshown in FIGS. 12 and 13. The two paddle sections 304 a and 304 b arepositioned with one paddle section on each side of the spinous process.The flanges 332 are placed under the lamina to maintain the position ofthe paddle sections 304 a and 304 b. In addition, the dorsallyprojecting lead connections 316 allows the paddle sections 304 a and 304b to cover the targeted nerve roots.

Referring now to FIG. 33, similar paddle sections 304 a and 304 b tothose shown in FIG. 32 are depicted on a single side of the spinousprocess. In addition, the paddle sections 304 a and 304 b of FIG. 33illustrate flanges 332 placed under the lamina to maintain the positionof the paddle sections 304 a and 304 b. The dorsally projecting leadconnections 316 allow the paddle sections 304 a and 304 b to cover thetargeted nerve roots.

FIG. 34 illustrates the use of paddle sections 1804 a′ and 1804 b′ ofelectrode paddle 1800′ where the paddle sections 1804 a′ and 1804 b′have been separated from one another and are placed to stimulate the L4,L5, S1 and/or S2 nerve roots unilaterally. FIG. 34 further illustratesthe location of a partial laminectomy, wherein some bone of the sacrumhas been removed so that the contacts 220 a-d of the paddle section 1804a′ are not pressed against the neural structures. However, the flange1904 is tucked under a portion of the sacrum to maintain the location ofthe paddle section 1804 a′.

FIG. 35 illustrates the use of paddle sections 1804 a′ and 1804 b′ ofelectrode paddle 1800′ where the paddle sections 1804 a′ and 1804 b′have been separated from one another and are placed to stimulate the S1and/or S2 nerve roots bilaterally. The flanges 1904 are tucked under aportion of the sacrum or lamina of the L5 vertebra to maintain thelocation of the paddle sections 1804 a′ and 1804 b′.

Referring now to FIG. 36, electrode paddle 1800′ is shown with itspaddle sections 1804 a′ and 1804 b′ still interconnected with theelectrodes positioned to stimulate the S1, S2, and/or S3-5 nerve rootson the left side of the spine. Bridging longitudinal flange 2100 extendsalong the longitudinal end of both paddle sections 1804 a′ and 1804 b′of electrode paddle 1800′ and interconnects paddle sections paddlesections 1804 a′ and 1804 b′.

Referring now to FIG. 37, electrode paddle 1800′ is shown with itspaddle sections 1804 a′ and 1804 b′ still interconnected with theelectrodes positioned to stimulate the L5, S1, and/or S2 nerve roots onthe left side of the spine. The flanges 1912 and 2100 are tucked under aportion of the sacrum or lamina of the L5 vertebra to maintain thelocation of the electrode paddle 1800′.

FIG. 38 illustrates another example of electrode paddle 1800′ being usedto with its paddle sections 1804 a′ and 1804 b′ still interconnected.For the example shown in FIG. 38, the electrodes are used to stimulatethe S2 and/or S3-5 nerve roots bilaterally.

Referring now to FIGS. 39-43, and by way of example and not limitation,several illustrative examples of the placement of the electrode paddlesof the present invention between the C1-C2 cervical vertebrae are shown.Referring now to FIG. 39, electrode paddle 1800′ is shown with itspaddle sections 1804 a′ and 1804 b′ still interconnected with theelectrodes positioned to stimulate neural structures of the spinalcanal. The electrode paddle 1800′ shown in FIG. 39 has its longitudinalaxis aligned substantially parallel to the axis of the spine. Theflanges 1912 and 2100 are tucked under a portion of the lamina of the C1and C2 cervical vertebrae to maintain the location of the electrodepaddle 1800′.

FIG. 40 illustrates a partial side view of the electrode paddle 1800′placed between the C1 and C2 vertebrae, wherein the vertebrae in aneutral position. FIG. 41 illustrates the electrode paddle 1800′ of FIG.40, but with vertebrae in extension. Here, the position of the lead 208and its connection to the electrode paddle 1800′ are preservedstructurally because the lead 208 extends from the electrode paddle1800′ in a substantially perpendicular orientation. This reduces thestress on the electrode paddle 1800′ and the lead 208, thereby helpingpreserve the integrity of the implanted stimulation components. This isin significant contrast stress conditions imposed on the electrode lead22 and electrode paddle 42 described above and shown in FIG. 1F.

FIG. 42 illustrates another example of electrode paddle 1800′ being usedto with its paddle sections 1804 a′ and 1804 b′ still interconnected.The electrode paddle 1800′ shown in FIG. 42 has its longitudinal axisaligned substantially perpendicular to the axis of the spine.

FIG. 43 illustrates the use of paddle sections 1804 a′ and 1804 b′ ofelectrode paddle 1800′ where the paddle sections 1804 a′ and 1804 b′have been separated from one another and are placed to stimulate theneural structures at C1-C2 bilaterally. As shown in FIG. 43, paddlesection 1804 b′ has been separated from paddle section 1804 a′ bydividing bridging longitudinal flange 2100. The flanges 1912 and 2100are tucked under a portion of the lamina of the C1 and C2 cervicalvertebrae to maintain the location of the paddle sections 1804 a′ and1804 b′.

Referring now to FIGS. 44-46, and by way of example and not limitation,several illustrative examples of the placement of the electrode paddlesof the present invention between the T7-T11 thoracic vertebrae areshown. Referring now to FIG. 44, electrode paddle 2200 is shown with itspaddle sections 2204 a and 2204 b still interconnected with theelectrodes positioned to stimulate neural structures of the spinal cordlocated between the T9 and T10 thoracic vertebrae. The dorsallyprojecting lead connections 2208 a and 2208 b allows the paddle sections2204 a and 2204 b to cover the targeted neural structures with the leads208 positioned to extend between the T9 and T10 vertebrae.

FIG. 45 illustrates the use of paddle sections 2204 a and 2204 ofelectrode paddle 2200 where the paddle sections 2204 and 2204 have beenseparated from one another and are placed to stimulate the spinal cordbetween the T9 and T10 vertebrae in the case of paddle section 2204 b,and the spinal cord between the T10 and T11 vertebrae in the case ofpaddle section 2204 a. Thus, one electrode paddle can be used tostimulate neural structures at a plurality of levels of the spine.

Referring now to FIG. 46, the electrode paddle section 2204 a of FIG. 45has been rotated 180 degrees to provide an alternate orientation forstimulation of the neural structures relative to that shown in FIG. 45.Thus, the asymmetrical electrode configuration of the paddle sections ofat least some embodiments of the present invention allow the electrodepaddles to be divided into paddle sections for modified treatmentorientations, as may be desired by the treating physician.

Embodiments of the present invention include an electrode paddle, suchas electrode paddle 1800, wherein one of the paddle sections, such aspaddle section 1804 a or 1804 b, is a blank; that is, it does notcontain any contacts 220 (or if it does have contacts, the contacts arenot interconnected to the implantable pulse generator, and/or they arenot controlled by the implantable pulse generator). A blank paddlesection may be used to augment securing the position of the paddlesection having an active contact, or the blank paddle section may beseparated from the paddle section having an active contact. Thus, forthe electrode paddles described herein, the electrode paddle may have atleast one detachably attached paddle section that has a contact.

Embodiments of the present invention include methods of using animplantable electrode paddle of the present invention. The methodincludes a surgeon making an incision for implanting an electrode paddleof the present invention. If the patient's physiological needs are suchthat the electrode paddle should be divided, the surgeon can separatethe paddle sections to accommodate the needs of the patient and implantthe paddle sections to stimulate the target neural structures. Thesurgeon may implant a new pulse generator with an electrode paddle ofthe present invention, or the surgeon may use a previously implantedpulse generator as the electrical source.

Embodiments of the present invention also include a method of assemblingan implantable neuron-stimulation system. The method includes the stepof providing an electrode paddle having a plurality of separable paddlesections, wherein in at least one paddle section the contacts areconfigured asymmetrically.

Embodiments of the present invention further include a method ofassembling an implantable system, the method comprising: providing apulse generator and an electrical lead, and further comprising the stepof preparing an electrode paddle by dividing the electrode paddle into aplurality of paddle sections.

Electrode paddles and their associated features may be made from one ormore materials that possess the appropriate strength characteristicsnecessary to withstand conditions from the body and associated implantswhen used in medical applications. In addition, the materials may bechosen to provide desired flexibility characteristics. In accordancewith embodiments of the present invention, examples of materials thatmay be used include, but are not necessarily limited to, silicone,polyether ether plastics, such as ketone (PEEK), polyether ketone ketone(PEKK), ultra high molecular weight polyethylene (UHMWPE), andpolymethylmethacrylate (PMMA); metals, such as titanium and stainlesssteel; composites; as well as other tissue compatible materials. Thematerial used will depend upon the portion of the device underconsideration, and certain materials may be more appropriate thanothers.

While particular embodiments of the present invention have beendescribed in some detail, it should be understood that other relatedembodiments are intended to be within the scope of the presentinvention. For example, other ways to functionally and structurallyprovide a flange or a dorsally projecting electrode lead are encompassedby the present invention, whether such structures employ all or onlysome aspects of the present invention, and/or whether such structuresare integrally made or form a connectable part of the an implantationsystem, and/or whether such structures include other features that arewell within the knowledge of those of ordinary skill in this art, and/orwhether such structures are conventional structures or those that may bedeveloped in the future.

The foregoing discussion of the invention has been presented forpurposes of illustration and description. The foregoing is not intendedto limit the invention to the form or forms disclosed herein. In theforegoing Detailed Description for example, various features of theinvention are grouped together in one or more embodiments for thepurpose of streamlining the disclosure. This method of disclosure is notto be interpreted as reflecting an intention that the claimed inventionrequires more features than are expressly recited in each claim. Rather,as the following claims reflect, inventive aspects lie in less than allfeatures of a single foregoing disclosed embodiment. Thus, the followingclaims are hereby incorporated into this Detailed Description, with eachclaim standing on its own as a separate preferred embodiment of theinvention.

While various embodiments of the present invention have been describedin detail, it is apparent that modifications and adaptations of thoseembodiments will occur to those skilled in the art. However, it is to beexpressly understood that such modifications and adaptations are withinthe spirit and scope of the present invention, as set forth in thefollowing claims.

What is claimed is:
 1. A method of assembling a neurostimulation systemthat is implantable in a patient to stimulate neural structures,comprising: providing an implantable pulse generator; providing animplantable lead for transmitting an electrical stimulation pulse fromthe implantable pulse generator; and providing an electrode paddlehaving a plurality of separable paddle sections, wherein at least afirst paddle section and a second paddle section of the plurality ofseparable paddle sections include a plurality of contacts; wherein atleast two contacts of the plurality of contacts of the first paddlesection are aligned along a first axis and wherein at least two contactsof the plurality of contacts of the first paddle section are alignedalong a second axis, and wherein the first axis of the first paddlesection is substantially perpendicular to the second axis of the firstpaddle section; wherein at least two contacts of the plurality ofcontacts of the second paddle section are aligned along a first axis andat least two contacts of the plurality of contacts of the second paddlesection are aligned along a second axis wherein the first axis of thesecond paddle section is substantially perpendicular to the second axisof the second paddle section; and wherein the electrode paddle iselectrically connected or interconnectable to the implantable pulsegenerator by the implantable lead.
 2. The method of claim 1, furthercomprising the step of providing a controlling function in theimplantable pulse generator, wherein at least two of the plurality ofcontacts can be individually or collectively controlled.
 3. An electrodepaddle for use in an implantable neurostimulation system for implantinginto a patient to stimulate neural structures within the patient, theimplantable neurostimulation system including an implantable pulsegenerator and an electrode lead, the electrode lead in electricalcommunication with the implantable pulse generator, the implantablepulse generator for sending an electrical current to the electrodepaddle by way of the electrode lead, the electrode paddle comprising: aplurality of paddle sections formed of an implantable tissue compatiblematerial including a first paddle section and a second paddle sectionwherein each of the plurality of paddle sections includes a stimulationsurface including a plurality of conductive contacts in electricalcommunication with the electrode lead and an opposing insulatingsurface, wherein each of the plurality of paddle sections has athickness between the stimulation surface and the opposing insulatingsurface, each of the paddle sections further including a lengthextending along a longitudinal axis between a first end and an opposingsecond end, and a width extending between a first lateral side and anopposing second lateral side, the length being greater than the widthand the width being greater than the thickness, the first paddle sectiondetachably attached to the second paddle section; a stabilization flangeformed of an implantable tissue compatible material located along atleast a portion of the first paddle section; a lead connection joined tothe opposing insulating surface of the first paddle section andextending substantially perpendicular away from the opposing insulatingsurface of the first paddle section, the lead connection spaced from thefirst end, second end, first lateral side, and second lateral side; anda plurality of electrical conductors extending through the leadconnection to the plurality of conductive contacts disposed on thestimulation surface of the first paddle section, wherein thestabilization flange extends laterally away from the first lateral sideof the first paddle section, the stabilization flange configured toengage adjacent tissue of a patient to stabilize the position of theelectrode paddle, and wherein the stimulation surface lies within afirst plane, and the stabilization flange lies within a second plane,the second plane intersecting the first plane.
 4. The electrode paddleas claimed in claim 3, wherein the first and second paddle sections areseparable along an orientation substantially coincident with alongitudinal axis of the electrode paddle.
 5. The electrode paddle asclaimed in claim 3, wherein at least two contacts of each of the firstand second paddle sections are aligned along a first axis and at leasttwo contacts of each of the first and second paddle sections are alignedalong a second axis, and wherein the first axis and the second axis aresubstantially perpendicular to one another.
 6. The electrode paddle asclaimed in claim 3, wherein at least one conductive contact of theplurality of conductive contacts of the first paddle section is offsetlaterally from a linearly aligned group of the plurality of conductivecontacts.
 7. The electrode paddle as claimed in claim 3, wherein thefirst and second paddle sections are detachably attached by an interiorpaddle section connector.
 8. The electrode paddle as claimed in claim 3,wherein the first and second paddle sections are detachably attached bya webbing bridge.
 9. The electrode paddle as claimed in claim 3, whereinthe flange comprises a gap, the gap extending from an outer lateral edgeof the flange to the at least one exterior side edge of the first paddlesection.
 10. The electrode paddle as claimed in claim 3, wherein thefirst and second paddle sections are separable along an orientationsubstantially coincident with a longitudinal axis of the electrodepaddle.
 11. The electrode paddle as claimed in claim 3, wherein thefirst and second paddle sections are separable along an orientationtransverse to a longitudinal axis of the electrode paddle.